PMA P210034
- Device
- Agili-C
- Applicant
- Smith and Nephew, Inc.
- PMA number
- P210034
- Product code
- QRU
- Decision date
- 2022-03-29
- Generic name
- Implant, resorbable, for articular osteochondral repair
- Approval order statement
- Approval for Agili-C. The Agili-C scaffold is indicated for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
Current openFDA PMA Record#
- Device
- Agili-C
- Applicant
- Smith and Nephew, Inc.
- PMA number
- P210034
- Product code
- QRU
- Generic name
- Implant, resorbable, for articular osteochondral repair
- Decision date
- 2022-03-29
- Decision code
- APPR
- Date received
- 2021-09-30
- Approval order statement
- Approval for Agili-C. The Agili-C scaffold is indicated for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).